01 1Novartis Pharmaceutical Manufacturing LLC
01 1Lithium carbonate
01 1Slovenia
Registration Number : 217MF10493
Registrant's Address : Verovskova ulica 57, 1000 Ljubljana, Slovenia
Initial Date of Registration : 2005-09-06
Latest Date of Registration : 2007-05-15
A Lithium Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lithium Carbonate, including repackagers and relabelers. The FDA regulates Lithium Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lithium Carbonate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Lithium Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lithium Carbonate supplier is an individual or a company that provides Lithium Carbonate active pharmaceutical ingredient (API) or Lithium Carbonate finished formulations upon request. The Lithium Carbonate suppliers may include Lithium Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Lithium Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Lithium Carbonate Drug Master File in Japan (Lithium Carbonate JDMF) empowers Lithium Carbonate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Lithium Carbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Lithium Carbonate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Lithium Carbonate suppliers with JDMF on PharmaCompass.
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